Oral Solid Dosage Forms Containing Amorphous Spray Dried Dispersions: Choices for First in Human Studies
The number of amorphous solid dispersions entering first in human (FIH) studies continues to increase, due to the growing number of novel APIs with a poor solubility profile, and associated bioavailability challenges. Spray drying is a useful technology for creating a form of amorphous solid dispersions called spray dried dispersions (SDDs). Spray drying a poorly […]
Assessing Bioavailability Enabling Technologies using Upperton Pharma Solutions Screening Platform – UpperSolv™+
Currently approximately 9 out of 10 new drugs entering clinical trials will fail before reaching approval. Many of these drugs will fail due to problems with ADME (absorption, distribution, metabolism and excretion) rather than lack of efficacy. One of the more common issues associated with ADME is the need for increasing bioavailability. Therefore, it is […]
Using Spray Drying to Develop Inhaled Dosage Forms
Pulmonary delivery is showing increased popularity as a viable dosage form for treating local airway diseases and offers additional potential for systemic drug delivery. Within this space there are a number of delivery approaches that can be undertaken. These include dry powder inhaled formulations (DPI) and pressurised metered Dose Inhalers (pMDIs). Each of these delivery […]
Selecting a Spray Dryer for Development Studies and Clinical Manufacture
Loading the Elevenlabs Text to Speech AudioNative Player… Talk to our experts Virtual Facility Tour When customers initiate discussions with Upperton, one of the first questions we are asked is “which spray dryer(s) do you have and how much material can they produce?” Whilst these are very pertinent questions, the answer is not a simple […]
API Challenges in early stage formulation development, part 2
Loading the Elevenlabs Text to Speech AudioNative Player… There are many challenges that face companies taking a NCE into early stage feasibility testing and beyond. Some of these challenges are specific to the physical and chemical properties of the molecule in question (e.g. hard to handle API) whilst other challenges are related to the embryonic […]
API Challenges in Early Stage Formulation Development, Part 1
There are many challenges that face companies taking an NCE into early stage feasibility testing and beyond. Some of these challenges are specific to the physical and chemical properties of the molecule in question whilst other challenges are related to the embryonic stage of development that these molecules are in (e.g. limited API). When early stage […]
Developing Oral Dosage Forms for Clinical Trials – Tablets vs Capsules
Dosage Form Selection Designing a Process for Tablet Manufacture Designing a Process for Capsule Manufacture FAQs Loading the Elevenlabs Text to Speech AudioNative Player… Dosage Form Selection Producing a spray dried powder is rarely the end of developing an oral dosage form pathway. Further processing is usually required in order to create a oral dosage […]
Spray Drying Process Development and Scale up
Upperton Pharma Solutions are one of the very few CDMO’s that have a bespoke, fully equipped non-GMP pilot plant designed to reduce the timelines and the costs for scale up and transfer of spray drying processes into GMP manufacturing. Spray Drying Development and Scale up Formulation and early process development studies are performed in the Upperton […]
Analytical Techniques for Biotherapeutics
Analysing Biotherapeutic Formulations There is growing interest in the use of spray drying to create biotherapeutic dry powder formulations. Spray drying is becoming increasingly viewed as a more cost-effective method for enhancing the stability of thermo-sensitive molecules (such as proteins, peptides, monoclonal antibodies and vaccines). A key aspect in the successful development of dry powder formulations […]
Biotherapeutic Formulation Development
Spray Drying Biotherapeutics Dry powder formulations of Biotherapeutics eliminate the need for expensive cold chain storage and facilitate supply chain management. Lyophilisation is traditionally used for the drying process, but in recent years the semi-continuous, robust and scalable qualities of spray drying have made it the drying process of choice. With expert formulation and process […]